FDG PET/MRI Evaluation of Facet Joint Pain

Molecular and Magnetic Resonance Imaging Biomarkers of Facet Joint Pain of the Lumbar Spine With PET/MRI

Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost wages, etc) annually. The most common source is low back pain (LBP), often from facet joints. The clinical evaluation of facet joints is challenging and anatomic imaging findings of facet joint; degenerative change; correlate poorly with pain. Therefore, it is difficult to select appropriate candidate patients/facet joints to treat. Misguided percutaneous treatment can cost thousands of dollars per session and delay diagnoses. Very limited retrospective information suggests that high grade peri-facet MRI signal change correlates to the side of LBP. However, this has not fully characterized the imaging findings and has not correlated to expert clinical exam/percutaneous response, precluding robust and meaningful clinical impact. Minimal retrospective data concludes inflammatory changes can be identified on FDG-PET exams, but the evidence of correlation to patient pain is lacking. Limited DWI exists for inflammatory spondyloarthropathies and myopathies, but is also lacking.

This is an exploratory study investigating the utility of FDG PET activity and MRI signal change around facet joints in the clinical management of low back pain. This study will help determine if such imaging biomarkers could change clinical management. Additionally, this will provide data that will be vital to planning a larger prospective study evaluating the ability of imaging biomarkers to predict response to comparison medial branch blocks and RF ablation for treatment of facet joint pain.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: FDG PET/MR examination.

Detailed Description

10 patients with a clinical suspicion of at least 60% likelihood that low back pain arises from the lumbar facet joints will be recruited in clinic. The clinicians will rate the likelihood clinically of facet joint origin of pain and will assign a theoretical treatment plan based on initial clinical impression. They will indicate which facet joints, if any, they would refer for percutaneous treatment. The patients will undergo and FDG PET/MRI of the lumbar spine with IV gadolinium. The MRI signal change and enhancement of the lumbar facet joints will be graded by 2 radiologists blinded to the clinical data. The FDG PET scan activity of the facet joints will be graded by two nuclear medicine radiologists blinded to the clinical information. The clinicians will then be segmentally unblended to the imaging data as follows: 1. facet joints with high grade MRI signal change, 2. facet joints with any MRI signal change, 3. facet joints with high grade PET activity, and 4. facet joints with any PET activity. At each of these 4 steps, the clinician will indicate if this information would have the potential to alter clinical care (assuming that the imaging biomarker in question would be a surrogate for inflammation and pain) and if the information is concordant to the clinical impression. The clinical course of each patients will be followed for 1 year after undergoing the PET/MRI examination.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Eligibility criteria - inclusion:

1. Male and female patients over the age of 50-100 years with clinically suspected facetogenic low back pain.
2. Patients must be considered to have at least a 60% chance of having facet joints as the major source of low back pain based on overall clinical impression.
3. All patients will undergo a standardized clinical exam by an experienced physical medicine and rehabilitation clinician to confirm clinical suspicion of axial low back pain.
4. Patients with either unilateral or bilateral axial low back pain may be enrolled.

Eligibility criteria - exclusion:

1. Pregnancy
2. Prior lumbar back surgery
3. History of endovascular repair of abdominal aortic aneurysm or other postoperative change likely to introduce imaging artifact to the lumbar spine
4. Suspected spine infection
5. Known osseous metastatic or other osseous malignancy
6. Facet joint percutaneous treatment within the past 2 months
7. History of major lumbar spine trauma
8. Inability to provide own consent
9. Claustrophobia, cardiac pacemaker/wires in place, any absolute contraindication to MRI
10. Impaired renal function indicated by a GFR less than 30
11. Gadolinium allergy
12. Highly radiosensitive medical conditions
13. Patients who are unable to lay quietly for 60 minutes of imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/MR recipients; All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.	Device: FDG PET/MR examination.; All recruited patients will undergo an FDG PET examination focused on the lumbar spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facet Joint High Grade FDG Activity Concordance to Pain	Concordance of high grade FDG scores with clinical impression	2 years
Facet Joint All Grades of FDG Activity Concordance to Pain	Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression	2 years
Facet Joint High Grade MRI Signal Change Concordance to Pain	Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression	2 years
Facet Joint Any Grade of MRI Signal Change Concordance to Pain	Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression	2 years
Facet Joint High Grade FDG Activity Potential Effect on Management	Number/percentage of subjects for whom high grade FDG scores would change clinical management	2 years
Facet Joint All Grades of FDG Activity Potential Effect on Management	Number/percentage of subjects for whom any grade FDG scores would change clinical management	2 years
Facet Joint High Grade MRI Signal Change Potential Effect on Management	Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management	2 years
Facet Joint Any Grade MRI Signal Change Potential Effect on Management	Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management	2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Vance T Lehman, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Back Pain; Arthralgia; Low Back Pain
• Other Study ID Numbers: 15-001228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO